FDA 483 - NutraStar, Inc. - April 24, 2018

An FDA inspection of ANS Nutrition, Inc. (formerly DNE Nutriceuticals, Inc.) in Farmingdale, NJ, revealed significant deficiencies in quality control and storage practices for dietary supplements. The firm failed to adequately test finished product batches for strength and composition, and did not ensure appropriate environmental conditions for storing ingredients and finished products. These observations indicate a lack of control over product quality and stability.